Can Talc Cause Cancer?

A jury recently awarded $72 million in a talcum-powder–ovarian cancer case, but the data linking the hygiene product to disease risk are inconclusive.

By Kerry Grens | March 2, 2016

WIKIMEDIA, MATERIALSCIENTISTLast week, jurors in Missouri concluded that Johnson & Johnson bore some responsibility in the death of Jackie Fox, who died of ovarian cancer. Fox’s family was awarded $72 million in a case against the pharmaceutical behemoth because, the jurors said, Johnson & Johnson failed to disclose that its talc-based feminine hygiene powder carried an ovarian-cancer risk.

“The message that was spoken loud and clear came from the jury last week,” Ted Meadows, an attorney with Beasley Allen—the firm that represented Fox’s family—told The Scientist. “They’re telling J & J it’s time to either remove talc from the market or allow women to make an informed choice by putting a warning on the bottle.”

Yet, according to the company, the jurors’ decision was not rooted in evidence. “The recent jury outcome goes against decades of sound science proving the safety of talc as a cosmetic ingredient in multiple products,” Johnson & Johnson said in a statement sent to The Scientist.

The truth, it appears, lies somewhere in between. Epidemiologic studies have produced mixed results, though many have found a slight increase in risk for ovarian cancer—roughly 30 percent—among women who use talcum powder in their genital areas. But as far as experimental evidence showing talc can cause cancer, “those studies are definitely needed,” said Katie Terry, an epidemiologist at Harvard Medical School who conducted a recent study looking at talc use and ovarian cancer risk.

Daniel Cramer, an epidemiologist at Brigham and Women’s Hospital, was among the first to publish results linking talc with ovarian cancer, finding a small increased risk among users. (Cramer is a paid consultant for plaintiff’s lawyers in talc-cancer litigation.) In 2000, for instance, he and his colleagues used data from the large Nurses’ Health Study and found a 40 percent increased risk for one type of ovarian cancer among women who used talc. The researchers saw no elevated risk for other types of ovarian cancer.

Last year, a case-control study led by Cramer’s team observed a 33 percent increase in ovarian cancer risk among women who applied talc genitally. And in a case report of a woman with ovarian cancer who used talc for decades, Cramer found evidence of the mineral in her pelvic lymph nodes. “Juries are very persuaded by the forensic evidence,” he told The Scientist. “If you put up a picture of a lymphatic channel with a talc particle in it, that’s pretty convincing.”

Joshua Muscat, a cancer epidemiologist at Penn State University, however, is not so convinced. (He is a paid consultant for defense attorneys in talc-cancer cases.) Case-control studies can suffer numerous limitations, he said, such as recall bias—women with cancer might recall a potentially hazardous exposure more readily—and challenges in determining exposure.

A more robust epidemiological design is the cohort study that tracks participants over time to see who develops disease. In 2014, using data from the Women’s Health Initiative, researchers from the University of Massachusetts-Amherst and colleagues found no link between genital or diaphragm-based talc powder use and ovarian cancer. “Here’s a true objective measure: talc-dusted diaphragms,” said Muscat. “There’s no increased risk at all.”

The study included only post-menopausal women, noted Terry, which could help explain the difference between the Women’s Health Initiative study and others, including her team’s own. In 2013, Terry and colleagues compiled data from eight case-control studies and found a 24 percent increased risk for epithelial ovarian cancer among women who used genital powders. From the questionnaires, the researchers could not definitively tell whether the products included talc.

“The data is suggestive that genital powder does increase risk,” Terry told The Scientist. She added that because ovarian cancer is rare, a 24 percent increase will likely not have a huge impact on the population. “It’s not like everybody who uses genital powder will get cancer. But there are very few modifiable factors for ovarian cancer.”

It’s not yet clear from published experimental data whether talc used in the genital area can indeed travel to the ovaries, increasing a woman’s cancer risk.

“There is no known biological mechanism—even if you thought talc could enter the reproductive tract and make contact with the ovaries—by which it could cause cancer,” said Muscat. “There are so many issues with this that it’s not really considered credible.”

A 2013 report by a Cosmetic Ingredient Review panel examined available toxicity and exposure evidence from studies on animals, cells, and humans, declaring talc safe for use. As for migration of talc to the ovaries, the results were inconclusive. Some experiments found talc in the ovaries of rats administered talc into the vagina, but did not find the same in rabbits and monkeys. A study of human ovarian tumors found talc particles in 75 percent of the cases, while five of 12 examined cases of healthy ovarian tissue samples taken from women with breast cancer also detected talc.

“There were no remarkable results found in studies examining the cellular effect of talc, such as cytotoxicity assays, assays examining the effect of talc on cell viability, or studies on the induction of apoptosis (among others),” the panel concluded. However, one of the studies the report cites that exposed human cell lines to talc found that it “increased proliferation, induced neoplastic transformation and increased [reactive oxygen species] generation time-dependently in the ovarian cells” and suggested the compound “may contribute to ovarian neoplastic transformation.” The Cosmetic Ingredient Review, an independent team funded by the Personal Care Products Council, did not respond to a request for comment.

Most health agencies have not declared talc a risk factor for ovarian cancer, save for the World Health Organization’s International Agency for Research on Cancer, which concluded in 2010 that “perineal use of talc-based body powder is possibly carcinogenic to humans.”

Cramer said he suspects the mechanism behind the link his team has observed between genital talc use and ovarian cancer has to do with inflammation. “It will be nice if we can put together an animal experiment to prove it,” he said. He agreed definitive experimental data are lacking. But it’s clear from last week’s trial against Johnson & Johnson that such evidence isn’t necessary to convince jurors.

Meanwhile, hundreds of cases are waiting to be heard, including two that Meadows will present in court next month.

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Data from the past deacde has shown that the most common and deadly form of ovarian cancer (serous cystadenocarcinoma) arises from epithelial cells covering the fallopian tube, in particular the finger-like projections that encircle the ovary known as fimbria. That's where one should be looking for talc particles and mechanisms of talc-induced neoplastic transformation, not the ovary.

A major confounding factor is the occurance of fiberous minerals, "asbestos", in most talc deposits. These known carcinogens have been noted in cosmetic talc products (e.g.,Gordon et al., 2014, DOI: 10.1179/2049396714Y.0000000081). I believe J&J claims they use a asbestos-free source.

If I were selling any product in the US, even water, I would include a warning that the product could cause any and all diseases to any and all parts of the body.

I would of course begin the disclaimer with a disclaimer that warns people to not read the full disclaimer and not use the product if they would be frightened by a disclamer that included the possibility of negative health outcomes.

It seems an utter travesty that a jury of peers contains none. Such subtle technical cases should be heard be people who can demonstrate that they are capable of understanding the scientific and statistical evidence presented in cases like this.

Such a case may be a chance to turn the US law system in a somewhat better direction: J&J should take the case higher and offer a the next instance - instead to pay money to the plaintiff and their lawyer - to fund research on the topic.

That might help to bring science further and make the hurdle to get big money to a pretended victim a bit higher.

To my opinion are epidemologic studies in humans not a good proof for an indidual case.

A typical example of the US medieval justice system in action, where decisions are made based on biased opinions rather than logic. As usual, the jury that I doubt understands elementary chemistry and much less cancer biology, made a decision for sure assuming that J&J has deep pockets and therefore it would not hurt them paying a few millions to the poor family. What the jury does not understand is that this type of baseless lawsuits increases the cost of medical care in the US. Interestingly is that during jury selection, anybody that has some education and can distinguish right from wrong is automatically disqualified; a situation that raises a lot of questions about the validity of those decisions. Another issue is that the scientific opinions come from scientists that have an active role as paid experts in these lawsuits, a situation that raises tremendous red flags about the fairness of their opinions.

I wrote the 1971 article in the Village Voice on the dangers of talc. My news article was based on the March, 1971 report "Talc and Carcinoma of the Ovary and Cervix" by Henderson et al. http://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.1971.tb00267.x/full . Summary: "an extraction-replication technique was used to examine patients with ovarian and cervical tumours. In both conditions talc particles were found deeply embedded within the tumour tissue. The close association of talc to the asbestos group of minerals is of interest." Your claim that talc and asbestos are "very different in structure and compositon" is not accurate. Both minerals are highly absorbent hydrous magnesium silicates, typically found in the same geological formations. The dangers of asbestos are well known. Considering the above article by Henderson, it is utter folly to bring talc particles in contact with the human body.

The key here is to be able to filter and view any kind of data for the actual, true Cause-and-Effects (inputs to outputs). Too often researchers use the old traditional and statistical regression methods (linear or non-linear) that assume a direct relationship between only the particular causes that the researchers chose to look at and the resulting effect, which may not be real. Advanced techniques that even the FDA mentions such as ANOVA can see which of the Causes are directly responsible for the "Outcome" (i.e. disease) and those Causes that are either weakly causing the disease or not at all.

Better methods such as Multivariate Statastitical Methods, ANOVA, and better ways to filter out the various Causes from the Effect (i.e., cancers) were not done by these scientistis. So sad. Even the FDA requires these advanced methods of pharmaceutical companies...

Nice Brent, wait until one of these products harms you or your family in some way, you will be the first one beating a path to an attorney with vengence on your mind. Your comment above is easily spoken by someone who obviously has never had the need for the US legal system you make snide remarks about.

Let's not kid ourselves J&J certainy knows the truth behind this whole matter, the fact that they have not offered a warning system shows their guilt, for what harm would it be to at least make consumers awre of the potential negative affects in useing their product. They don't do this for then it would imply guilt, which if they are not guily and their product is as safe as they say it is, then they could at least warn certain consumers who use this product to consider using an alternative product.

Here is the smoking gun, the whole hospital system in the entire United States has banned the use of any powers within their systems, includeing the use on infants, and women- Why is this? Because the whole establishment knows, but to admit the product is unsafe would be catastrophic at this point, they need to get some of the appeal process complete, and then a value will settle out as to what a death from this is worth, or what a uterus is worth, then guilt will be admitted and payouts will ensue- watch and you will see this unfold over the next few years-